FDA 483 - Covis Pharma GmBH - August 03, 2011

AMAG Pharmaceuticals, Inc. in Lexington, MA, was cited for multiple deficiencies related to its drug product, Gastromark. The inspection revealed failures in thoroughly reviewing discrepancies, conducting timely annual product reviews, and submitting required reports to the FDA. These issues include delayed field alert reports, and late annual adverse drug experience and general annual reports.